SUMMARY

• I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment.
• Produce statistical documentation and communicate with senior - level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels.

TECHNICAL SKILLS

• Policy/Procedure Development and review
• Change Control and Global Change Control
• Solid Dose, Liquid Dose, Sterile Product, Aerosol, Transdermal Patches, Injectable Products, Medical Device
• Microbiology Operations
• Trackwise: CAPA and Change Control
• Documentation
• Validation (IQ, OQ, PQ)
• Sharepoint, Teamspace
• MIDAS
• Process Improvements
• QUMAS, Documentum
• Product/Customer complaints
• Training Database System User: MyLearning, Eduneering, Trac 6.4, TM2000
• GMP Training
• eProgesa User
• Audit - internal and external
• Batch Record and Device History Record Review and Release
• Metrics and Trend Analysis
• SAP user 21 CFR Part 210-211, 21 CFR Part 11,
• 21 CFR Part 58, 21 CFR Part 820, ICH Q7, Q8(R2), Q9, Q10, ISO 9001, 17025, 13485

PROFESSIONAL EXPERIENCE

Confidential, Bryan, TX

Quality Assurance Supervisor

Responsibilities:

• Review manufacturing activities and ensure compliance with SOP and regulatory requirements.
• Perform final review and release for all product shipments and associated documents to meet customer specifications.
• Validated refrigerators, freezers, Haemonetics PCS 2 plasma collection equipment, and other equipment as necessary.
• Communicate with Operations management regarding daily quality assurance/control issues affecting donor suitability and product quality.
• Develop and implement Corrective/Preventive actions when necessary.
• Perform quality audits to ensure the integrity of the quality system(s) and prepare staff for on-going or upcoming customer, regulatory and corporate audits.
• Work with management in completing audit responses, including corrective/preventive action(s), and ensure responses are done in a timely manner.
• Perform focused audits to ensure employees correctly perform procedures and to identify any deficiencies and work with training staff to correct issues
• Assist management to support center compliance and Key Performance Indicators.
• Assist management and training staff in communicating SOP and regulatory changes and to ensure documentation is complete and accurate.
• Review center logs and records to ensure information is accurate and/or legible and to ensure Good Documentation Practices are followed.
• Analyze tracking and trending data and determine actions needed to ensure quality and improve trending.
• Receive and track complaints.

Confidential, Flanders, NJ

Contractor - Supplier Quality Engineer III

Responsibilities:

• Provide support to the New Product Development activities.
• Interface with R&D, Engineering and Operations to ensure the successful transfer to Production.
• Work with suppliers to ensure incoming materials/components meet with specifications.
• Review and approval of non-conformances, ensuring prompt resolution of issues and continuous supply of material/components.
• Assess supplier’s capabilities to perform inspection of components. Conduct quality audits as required.
• Analyze failure, corrective and preventive action submitted by suppliers for adequacy.
• Gathering and analysis of quality data for trending purposes using software tools such as MiniTab and Microsoft Excel. Preparation of QA reports.
• Maintained Communication with vendors and suppliers to ensure the GMP compliance.
• Data entry into SAP system in support of Third Party Quality activities.
• Assist Quality manager in establishing, implementing and maintaining the quality management system.
• Provide support during audits.
• Support test method validation studies.
• Create and maintain inspection plans for parts/components using SAP Quality Module (QM).

Confidential, NJ

Contractor - Quality Assurance Records, Release Coordinator

Responsibilities:

• Review Device History Records (DHR) and release products with the Enterprise Resource Planning System (ERP).
• Used Trackwise system to ensure any issues were resolved prior to release of product.
• Facilitated resolutions for any discrepancies in DHR records before the product can be released.
• Provides data/metrics related to accuracy, completeness and cycle times for records being reviewed.
• Reviewed, investigated and tracked complaints to determine cause and resolution via the system software Trackwise.
• Maintained Communication with vendors and suppliers to ensure GMP compliance.
• Data entry into Trackwise system in support of Third Party Quality activities.
• Identify areas in need of improvement regarding accuracy, completeness and cycle times.

Confidential, Summit, NJ

Contractor - Research Commercialization Quality, Quality Reviewer II

Responsibilities:

• Performed quality review of all Standard Operating and Laboratory procedure revisions.
• Performed audits on various functional areas related to Research Commercialization Quality, such as, laboratories, manufacturing, training, etc.
• Assisted in Creating Quality review, audit and training metrics on a monthly and quarterly basis.
• Document Liaison for the management and archiving of GMP documents.
• Used the following quality management tools; MIDAS, Mylearning, Sharepoint, Gap Analysis Tracking system, eDiscovery, Trackwise and Records Management system.
• Review and revise global raw material Manufacturing Processes, Methods and specifications.
• Mentor Quality Technicians on the GMPs of reviewing and updating manufacturing, methods and specifications.

Confidential, NJ

Contractor - Quality Assurance, Senior QA Specialist

Responsibilities:

• Create and maintain Raw, Active and Packaging Materials program
• Maintain, update and oversee the Training program.
• Performed and reviewed investigations and CAPA.
• Created and revised Production and Raw Material monographs for various international market sites.
• Created and revised International Analytical and Manufacturing Procedures.
• Interacted with sites internationally to clarify/gather analytical/manufacturing information.
• Initiated and tracked changes using the Trackwise software database.

Confidential, East Hanover, NJ

Contractor - GMP Training

Responsibilities:

• Performed SOP and technical training for laboratory personnel
• Provided GMP training covering areas such as Change Control, CAPA, Investigations and Audits

Confidential, NJ

QA Supervisor

Responsibilities:

• Assisted in creating and maintaining Actavis’ new employee orientation training program.
• Created and maintained Training Syllabi/Curricula and Training Materials for GMP Training.
• Attended Train the Trainer seminar.
• Assisted with and created customized reports with TM2000 designer for Actavis’ training manager database (i.e. Training gap analysis, Training logs, Training Metrics).
• Created and revised task qualification checklists for Manufacturing Operations and Quality Control to ensure that only qualified employees are performing tasks assigned.
• Scheduled and performed training for SOPs, GMP and Safety issues and ensured that training complied with regulatory and company policies and procedures.
• Member of the Training Steering Committee.
• Change Control Review Board Head for all Major Change Controls and Technical Transfers.
• Created Annual Product Review reports for all Change Controls related to a product.
• Reviewed and resolved incoming internal customer complaints, to include, general QA complaints.
• Created process of notifying the change initiator when change controls were becoming overdue.
• Reduced average time of change control approval from 18 days to 9 days.Standard Operating Procedures
• Created, revised and updated Standard Operating Procedures.
• Created a Standard Operating Procedure review process that details an SOP’s current status as being current or requires revision.
• QUMAS Check-in documents, release panel and setup new User accounts.

Confidential, NJ

QA Supervisor

Responsibilities:

• Reviewed, investigated and tracked Deviations/Quality Events to determine cause and resolution via the system software Trackwise.Audits
• Performed Audits of quality systems, such as, Training, Change Control, Documentation, Laboratories and SOPs.Validation
• Point of Contact for the global validation project of the Training Manager 2000 training database.
• Authored the Validation package and executed and reviewed protocol for the TM2000 training database.
• Team member for the validation of Trackwise and QUMAS software systems.
• Assisted in validation projects in manufacturing and QC.
• Functioned as supervisor for all Documentation systems, such as, Change Control, Batch record setup/review and Document release (i.e. SOPs, Methods, Specifications, Forms, Lists) in the QUMAS database.
• Created and maintained excel spreadsheets ( w/ tools for filtering, formulas, graphing) to create metrics for the number of SOPs released, Investigations, Change Controls etc., that were opened and completed per month and quarterly.
• Created computer software and manufacturing validation packages and test scripts.
• Reviewed computer software and manufacturing validation packages and test scripts for accuracy, completeness and for any potential GMP issues.
• System Administrator for the Training Manager 2000 training database.

Confidential

QA Manager

Responsibilities:

• Managed and supervised six individuals in the Quality Assurance Department.
• Reviewed and resolved all incoming complaints from external and internal customers.
• Scheduled workload for Quality Assurance department on a daily and weekly basis.
• Reviewed and investigated complaints to determine cause and resolution.
• Reviewed and approved protocols, SOPs, validations, test scripts and reports.
• Updated and maintained Master Schedule of GLP Studies.
• Updated and maintained companies Quality Manual.
• Hosted and successfully attained ISO guide 17025 certification for testing laboratories.
• Scheduled and performed internal audits of GLP studies and internal quality systems, and external audits of vendors and suppliers to ensure compliance to GMP and GLP regulations.
• Hosted FDA regulatory, ISO and sponsor /customer audits.
• Maintained and performed GMP/GLP training and training records.
• Scheduled and maintained calibration and calibration log books of various testing equipment.
• Created and maintained excel spreadsheets for the number of customer and regulatory audits per month and GLP studies opened, closed and in-progress per month.

Confidential

Senior Microbiologist

Responsibilities:

• Performed sterility, release, stability, Bioburden, environmental and USP particulate matter testing.
• Performed standard microbiological tests on raw materials and finished products.
• Validated and System Administrator for the Vitek (bioMerieux) Identification System.
• Performed microbial identification using the bioMerieux API and Vitek Identification systems.
• Develop test methods, including validation of methods according to cGMPs.
• Authored and revised Standard Operating Procedures (SOPs), protocols and Monograph’s.
• Trained laboratory personnel on cGMPs and SOPs.
• SAP user for ordering required materials, part, equipment for the Microbiology Dept.
• Created and maintained excel spreadsheets for Trending Analysis and metrics using filters, formulas and Pivot Tables as needed. Created graphs for a visual view of monthly metrics.